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NOT YET RECRUITING
NCT06846424
PHASE1

SCT-001 CAR T Cells Therapy for Relapsed and Refractory Ovarian Cancer

Sponsor: Shanghai Gynecologic Oncology Group

View on ClinicalTrials.gov

Summary

This study is an open-label, dose-escalation, investigator-initiated phase I interventional clinical study. To evaluate the safety, tolerability and preliminary efficacy of SCT-001 CAR-T cell injection in subjects with relapsed and refractory epithelial ovarian, fallopian tube and peritoneal cancer, and to explore the pharmacokinetic characteristics, biomarker changes and immunogenicity of SCT-001 CAR-T cell injection in subjects with relapsed and refractory epithelial ovarian, fallopian tube and peritoneal cancer. In this study, two trial cohorts were set up, cohort 1 was the intraperitoneal route of administration, and the subjects enrolled in cohort 1 needed to meet the conditions for intraperitoneal administration ((1) the subject had a large amount of ascites, (2) the subject was suitable for peritoneal catheterization, (3) the subject had no severe abdominal adhesions, and (4) the subject agreed to undergo intraperitoneal surgical catheterization for intraperitoneal administration); Cohort 2 is the intravenous route.

Official title: A Clinical Study to Evaluate the Safety and Tolerability of SCT-001 CAR-T Cells in Patients with Recurrent and Refractory Epithelial Ovarian Cancer, Fallopian Tube Cancer, and Peritoneal Cancer.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2025-06-01

Completion Date

2030-06-01

Last Updated

2025-02-26

Healthy Volunteers

No

Interventions

BIOLOGICAL

SCT-001 CAR-T cells

SCT-001 CAR-T cells are autologous-derived CAR-T cell products, which transduce second-generation CAR targeting TAG-72 into patient autologous T cells by lentiviral transfection, and knock out immunosuppressive related genes by CRISPR/Cas9 technology to enhance the anti-tumor function of CAR-T cells.

Locations (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China